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Sr. Software Quality Engineer

Company: Boston Scientific
Location: Valencia
Posted on: September 16, 2021

Job Description:

A leading medical device client in Valencia, CA is looking for a Sr. Software Quality Engineer to join the Neuromodulations Quality division. This Core Quality Team of Product Software Quality Assurance Engineers is embedded within R&D to support the development or use of Neuromodulations software products lines. The responsibilities of this group are highly user-centric focused, ensuring top-quality usability for users (physicians/patients), quality of software systems, validate product software and firmware requirements, and security and compliances.



This Engineer will be responsible for providing Quality Engineering Input to all aspects of Software and Firmware Quality Assurance activities which include: software validation/testing activities, adhoc testing, writing manual test scripts from scratch, writing validation protocols, and reporting/documentation. They will oversee design, development, and test of software during the entire Development Life Cycle, and will constantly be testing the usability of each product (i.e. how is the product used by the physician or patient, flow of the user interface, adhoc testing, etc.). The ideal candidate is team-oriented with people skills and positive can-do attitude in dealing with a large number of customers, and several competing tasks from various departments (R&D, Marketing, Manufacturing, Quality and Regulatory, Clinical, Project Management, etc.).



Responsibilities Include:

Review and approve documentation associated with user requirements, hazard analysis, functional and design specifications, design reviews, test protocols, and requirements traceability.

Validation activities: Reviews of Marketing specifications, Design Requirements, Functional, Architectural, and Module Design Details, Code and Design reviews, Unit tests, Integration tests, System level (black box), Structural (white box), test automation, ad-hoc/exploratory test activities, and Risk Management and Use and Design FMEAs.

Creation and execution of Validation protocols to perform System level testing of our products and report any issues discovered.

Perform review of design, development, and testing of software and firmware

Validation of custom and off-the-shelf software

Actively contributing to all aspects of Software and Firmware Quality Assurance activities in an FDA-Regulated Active Implantable Medical Device environment.

Ensures the quality of software systems, validate product software and firmware requirements, security and compliances.

Oversee design, development, and test of software related to all of the Neuromodulation product lines during their entire Development Life Cycle, from requirements gathering phase to the retirement phase.


Experience in software design assurance in the medical device industry

Experience with hardware/embedded software/firmware

Experience with digital health, Health IT or mobile medical applications

Working knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications
4+ years of manual software testing/design assurance/validation for commercial products in a highly regulated industry (Medical/Med Devices/Biomedical, Government, Aerospace, Automotive, Aviation, etc.)

Knowledge of mobile application development/testing (iOS & Android) and Bluetooth (BLE) technology

Experience manually testing on UI and Web applications

Programming languages: C# (preferred), PHP, Java/JavaScript, Python

Highly skilled in writing vaildation protocols, manual test scripts, and regulated reporting/documentation (Cockpit or other tools)

Understanding of Software Development Life Cycle using Agile best practices

Experience working cross-functionally with various departments (R&D, Marketing, Manufacturing, Quality and Regulatory, Clinical, Project Management, etc.)

BS degree in Computer Science, Software Engineering, Informatics, Biomedical, related technical field or equivalent practical experience

Understand aspects of HIPAA and GDPR compliance practices

Keywords: Boston Scientific, Los Angeles , Sr. Software Quality Engineer, Other , Valencia, California

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